ASK-PrEP (Assistance Services Knowledge-PrEP)

Launched by FRIENDS RESEARCH INSTITUTE, INC. · Jun 28, 2023

Keywords

ClinConnect Summary

The ASK-PrEP trial is a study designed to help HIV-negative transgender women and men who have sex with men and are struggling with substance use disorders (SUD). The goal is to see if a special program called "ASK-PrEP Stepped Care" can effectively support these individuals in reducing their risk of HIV. Participants will be divided into two groups: one will receive the ASK-PrEP support, which includes five sessions over three months with weekly text messages, while the other will receive standard care. Those who respond well to the support will continue for another three months, while those who don't will receive extra help focused on their substance use.

To be eligible for this study, participants must be 18 years or older, identify as a transgender woman or a man who has sex with men, be HIV negative, and meet certain criteria indicating they are at high risk for HIV. They also need to have a substance use disorder, but those who only use cannabis will not qualify. If someone is interested in joining, they can expect a supportive environment with regular check-ins and resources to help improve their health and well-being. It’s important to know that if a participant has serious kidney or liver issues, they may need to leave the study temporarily but can reapply once their health improves.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • self-identified transgender woman or MSM
• • ≥18 years old
• • verified HIV negative
• • identified as high risk for HIV based on the Los Angeles County criteria
• • SUD (injection and non-injection; excluding cannabis (CUD) only
• For those who have already initiated PrEP there is an additional eligibility criterion:
• • non-protective prophylaxis defined as missed ≥4 doses of PrEP/week during any week in the previous 30 days
• • no PrEP care visits in the past 3 months
• • willing to provide informed consent; and
• • willing to comply with study requirements.
• • Should a participant be identified as having kidney or liver dysfunction sufficient to contraindicate PrEP use (creatinine clearance \<60 mL/min), that individual will be withdrawn from study participation but may re-screen for eligibility once adequate renal and/or liver function has been established and medically documented (≥60 mL/min).
• Exclusion Criteria:
• • does not identify as a trans woman or male who has sex with men
• • under 18 years of age
• • HIV positive status
• • not identified as high risk for HIV based on the Los Angeles County criteria
• • no verified SUD or only CUD
• • if already initiated PrEP: PrEP adherent and PrEP care visits in the past 3 months
• • unwilling to provide informed consent
• • unwilling to comply with study requirements;